Cipla Ltd. announced that its wholly owned U.S. subsidiary was voluntarily recalling six batches of its oral inhalation drug from the market.
According to analysts, that could indicate that the company's Pithampur, Madhya Pradesh plant where the product is being manufactured may not receive clearance from the U.S. Food and Drug Administration. The unit is has already been flagged by the regulator over rising recalls.
The company disclosed that "Cipla USA Inc. is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level", according to an exchange filing.
These six batches, which have an expiry date of November 2023, were distributed nationwide to wholesalers and retailers, and the company is arranging for them to be returned and replaced.
The company didn't immediately respond to BQ Prime's queries.
This recall in the U.S. was due to a market complaint for a single inhaler with a leak in valve. "Out of an abundance of precaution, the above-mentioned six batches manufactured using the same lot of valves are being recalled," the company said.
Monish Shah, a pharma analyst with Antique Broking, said Albuterol is a critical product for Cipla, contributing around 15% to U.S. revenue and about 3% to total revenue in FY23. That's despite its market share falling to 10% versus around 16% last year in April, while competitor Lupin Ltd. maintains 16%, he said.
Albuterol, he said, is manufactured at the Pithampur unit of the company. This unit was last inspected by the FDA in February 2023 with eight observations, one highlighted the increased quantum of product recalls from the unit.
"The recall is likely to create a higher probability of a warning letter for the unit, and we believe Cipla is likely to lose further market share in its key product gAlbuterol," he told BQ Prime.
A warning letter suggests failure to promptly correct the matter may result in enforcement action without further notice.
The voluntary recall hints at the fact that issues at the plant are still not resolved, Vishal Manchanda, pharma analyst with Systematix, told BQ Prime. While the U.S. FDA outcome on the inspection is still awaited, an 'official action indicated' status—which means unless the objectionable conditions found at the facility on the inspection are not resolved and new approvals will be held back—in such a situation is very likely to come through, he said.
IIFL Securities pharma analyst Rahul Jeewani, too, anticipates a warning letter based on the observations made by the U.S. FDA on inspection of the facility.
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